August 10, 2023 - Colgate-Palmolive Company today announced a voluntary consumer level recall of six lots of its hello® Wild Strawberry Fluoride Toothpaste sold in the United States. 

The product is being recalled because some of the tubes are incorrectly labeled as hello® Fresh Watermelon Fluoride-Free Toothpaste rather than having the correct label for hello® Wild Strawberry Fluoride Toothpaste, which contains the active ingredient sodium fluoride and is regulated as an over-the-counter (OTC) drug to help protect against cavities.  The outer carton correctly identifies the contents of the tube as hello® Wild Strawberry Fluoride Toothpaste.

The tube does not display a required Drug Facts Box that discloses the presence of fluoride or directions for use. It also does not display warnings required of all fluoride toothpaste, including that the product should be kept out of reach of children under six and to get medical help or contact a Poison Control Center right away if more product than used for brushing is accidentally swallowed. The absence of the appropriate labeling creates the potential for unintentional exposure to fluoride. Exposure to too much fluoride (such as, for a very young child, ingestion of a third of a tube of toothpaste) can cause adverse reactions with a range of symptoms such as abdominal pain, diarrhea, vomiting, and potentially more serious adverse health consequences. 

To date, Colgate-Palmolive has not received any reports of adverse events related to this recall.

 

See the table below for six lot codes and associated UPC numbers impacted by the recall.  For products still in the outer carton labeled as hello Wild Strawberry Fluoride Toothpaste, the lot code and UPC can be found on one of the end flaps of the carton, printed in black ink.  For toothpaste tubes already removed from the carton, which may be labeled as hello Fresh Watermelon Fluoride-Free Toothpaste, the lot code can be found on the end seal of the tube (opposite end from the cap), with the lot code visible from the front of the tube.  Also see the images below of the impacted products.  

 

No other hello® toothpastes or other products are in the scope of this recall, and they may continue to be used as intended.

The products were sold by select retailers at stores in the United States and online. Colgate-Palmolive has notified its retailers to remove any remaining recalled product from shelves.  Colgate-Palmolive will also offer reimbursement to consumers who have purchased products impacted by this recall.  Consumers should stop using the product, take photos of the tube and box (if they still have them), or note the lot code and UPC bar code, submit for reimbursement and appropriately discard the recalled products.

 

Consumers with questions regarding this recall may contact Colgate-Palmolive at 1- 855-554-7567 Monday through Friday, 9:00 a.m. to 5:30 p.m. Eastern Time. Consumers may also visit www.hello-products.com for more information and to learn how to receive reimbursement for eligible products.  Consumers should contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to using this product. 

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.